Dr. pen microneedling devices are not authorized for sale and may pose health risks
What the notice records
| Product | Dr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions. Sold in various colours and styles. |
|---|---|
| Issue | Unauthorized product |
| What you should do | Do not use or buy unauthorized Dr. pen microneedling pens and cartridges or receive services at spas or from estheticians using these devices.Consult your healthcare professional if you have used these products, or have had them used on you, and you have health concerns.Only seek microneedling treatment from an experienced professional, as they can assess the benefits and risks of microneedling treatment for your individual health circumstances.Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).Report adverse effects or complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.What is Health Canada doing?Health Canada continues to follow up with companies (manufacturers, importers, distributors, and retailers) selling unauthorized microneedling devices and to take action on complaints received by the Department. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of these devices into Canada.Related linksSafe medical devices in CanadaBuying medical devices from the internetMedical Devices Active Licence Listing (MDALL)Health Canada reminds that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spas (March 27, 2019)Plasma pens are not authorized in Canada and may pose health risks (November 26, 2018)Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks (September 13, 2019) |
| Category | Medical devices |
| Publishing body | Communications and Public Affairs Branch |
| Class | Class not stated |
| Last updated | 2021-12-16 |
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